Mylan to market Lupin’s Enbrel biosimilar outside US

Mylan has joined with India’s Lupin to market a biosimilar of Amgen/Pfizer’s inflammatory diseases blockbuster Enbrel (etanercept) in ex-US markets.

Approved in a range of diseases including rheumatoid arthritis and psoriasis, Enbrel is one of several anti-TNF class drugs that are now facing cheaper competition from biosimilars – near copies of biologic drugs that have been clinically proven to match the originator in terms of safety and efficacy.

Enbrel biosimilars from Novartis’ Sandoz division, and Samsung Bioepis are already on the market in the EU.

Sandoz’s Enbrel biosimilar is also approved in the US, but launch has been delayed pending the outcome of a trial, where Amgen is claiming the drug has patent protection until 2029.

Nevertheless sales are slipping in an increasingly competitive market, and were down 6% in Q1 to just over a billion dollars, according to Amgen, which markets the drug in the US and Canada.

Pfizer markets Enbrel outside of the US and Canada and global sales of the drug totalled $11.6 billion in 2017, according to figures from IQVIA.

Under the deal announced today, Mylan will market a proposed Enbrel biosimilar from Mumbai-based Lupin in Europe, Australia, New Zealand, Latin America, Africa and most markets throughout Asia.

Lupin completed phase 3 development of the biosimilar in February and has filed it for approval with the European Medicines Agency, and plans submissions with other regulators.

Vinita Gupta, CEO of Lupin, said: “We are extremely pleased to announce this partnership as both Lupin and Mylan share a commitment to bring affordable and high quality medicines to market, especially in areas of unmet need.”

“Mylan is well-positioned to commercialise our etanercept biosimilar given their significant expertise and global infrastructure. This partnership enables us to accelerate our etanercept market plans across multiple regions globally, as we continue to advance our pipeline of biosimilar candidates.”